Despite the growing market demand for a consumer-friendly energy balance monitor, there are no commercially available solutions satisfying consumer needs. Valencell's long-term goal is to provide a seamless, wearable platform for health and fitness monitoring that is autonomous, user-friendly, comfortable for daily use, accurate in multiple life activities, and able to provide actionable feedback to the user. This preventive healthcare platform will provide end users, their doctors, and their trainers with easy-to-use, actionable feedback promoting a healthy lifestyle. Valencell has previously developed and alpha-tested the Healthset(R), an autonomous wearable health and fitness monitor that measures vital signs and physical activity and presents this information graphically on a smartphone. While the Healthset(R) measures physical activity of various intensity levels, it does not contain algorithms for processing energy expenditure assessments from raw physical activity data. Experimental evidence suggests that Valencell's Healthset(R) algorithms can be augmented to provide accurate energy expenditure assessments for daily life activities, suitable for clinical, academic, and consumer applications. Thus, the specific goal of this Phase I feasibility study is to validate the Healthset(R) as a seamless energy expenditure monitoring tool. In this NIH Phase I program, Valencell and collaborators at the Duke University will: 1.) fabricate pre-designed Healthset units optimized for measuring energy expenditure, 2.) collect time-correlated Healthset(R) data in a 10-person indirect calorimetry study, 3.) generate statistical models for energy expenditure, and 4.) validate these models in a second clinical study. This Phase I program will deliver the preliminary performance specifications for the Healthset(R) energy expenditure monitor used in multiple physical activities. The opportunity for assessing calories consumed will also be addressed in the final report for a complete energy balance monitoring platform. PUBLIC HEALTH RELEVANCE: Modifiable health risk factors such as high stress, poor diet, and a sedentary lifestyle account for 25% of all medical expenses and millions of deaths per year worldwide. Seamless, accurate, real-time feedback on personal health and fitness can empower individuals to live healthier lives, saving trillions in medical expenses. The energy balance monitoring technology proposed in this Phase 1 SBIR would make healthy living easier, more effective, and more affordable.